Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children

NCT01254175 | Completed Phase 1 DMC

• 3 other identifiers: P109611796IMPAACT P1096
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 8

Brief Summary

Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.

Conditions

Parainfluenza Virus 3, Human

Outcome Measures

Primary Outcomes (2)

• Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study

  Measured at Days 0-18 after each vaccination

• Proportion of participants that develop 4-fold or greater rises in hemagglutination inhibition (HAI) antibody titer following 2 doses of vaccine

  Measured through 31 days after the second vaccination

Study Arms (2)

rHPIV3cp45 Vaccine

EXPERIMENTAL

Participants will receive one dose of the rHPIV3cp45 vaccine at baseline and a second dose at Month 6.

Biological: rHPIV3cp45 Vaccine

Placebo Vaccine

PLACEBO COMPARATOR

Participants will receive one dose of the placebo vaccine at baseline and a second dose at Month 6.

Biological: Placebo Vaccine

Interventions

rHPIV3cp45 Vaccine BIOLOGICAL

10\^5 TCID\^50 of rHPIV3cp45 vaccine, delivered as nose drops

rHPIV3cp45 Vaccine

Placebo Vaccine BIOLOGICAL

Placebo vaccine, delivered as nose drops

Placebo Vaccine

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/guardian(s) of participants can demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following a detailed explanation of the study
• Seronegative for HPIV3, as defined by serum antibody titer hemagglutination inhibition (HAI) less than or equal to 1:8, as determined within 30 days prior to inoculation
• Medical history has been reviewed and a physical examination indicates that participant is in good health
• In the view of the site investigator, participant has received routine immunizations appropriate for age, administered at least 2 weeks prior to study entry (inactivated and subunit vaccines and rotavirus vaccine), or at least 4 weeks prior to study entry (live vaccines except rotavirus vaccine)
• Available for the entire study period and parent/guardian can be reached by telephone for post-inoculation contacts
• For children born to HIV-infected women, the child can be considered HIV-uninfected if he/she has either two negative polymerase chain reaction (PCR) tests with one collected at greater than 1 month of age and one collected at greater than 4 months of age, or two negative antibody tests
• If there is an immunocompromised child in the household who is less than 5 years of age, his/her last CD4 count must be greater than 15%

You may not qualify if:

• Known or suspected impairment of immunological functions, HIV infection, or currently (within the 30 days prior to study entry) receiving immunosuppressive therapy, including systemic corticosteroids (NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable.)
• Bone marrow/solid organ transplant recipients
• Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
• Previous immunization with HPIV3 vaccine
• Previous serious vaccine-associated adverse event or anaphylactic reaction
• Known hypersensitivity to any vaccine component
• Lung or heart disease, including reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy in the 12 months before study entry may also be enrolled.
• Premature infants (born before 37 weeks gestation) if less than 12 months of age
• Members of a household which contains immunocompromised individuals (including, but not limited to, those with HIV-related immunodeficiency, defined as CD4 count less than 300 within the 6 months prior to study entry, or any household members who have received chemotherapy within the 12 months prior to study entry). More information on this criterion can be found in the protocol.
• Members of a household that contains infants less than 6 months of age
• Attends day care with infants less than 6 months of age and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. (Facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.)
• Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or until the final follow-up blood draw
• Fever (rectal temperature of greater than or equal to 100.7 F), acute upper respiratory illness (including nasal congestion significant enough to interfere with successful vaccination), or acute otitis media
• Received any killed or subunit vaccine or rotavirus vaccine within the last 2 weeks; any live vaccine, except rotavirus, within the last 4 weeks; or gamma globulin (or other antibody products) within the past 3 months
• Received short-term systemic antibiotics for an acute illness within the 5 days prior to vaccination, or is currently receiving long-term prophylactic antibiotics (NOTE: Topical steroids, topical antibiotics, or topical antifungal preparations are permitted.)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (8)

Miller Children's Hosp. Long Beach CA NICHD CRS

Long Beach, California, 90806, United States

Location

UCSD Mother-Child-Adolescent Program CRS

San Diego, California, 92103, United States

Location

Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

Seattle Children's Hospital CRS

Seattle, Washington, 98105, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (2)

• Karron RA, Belshe RB, Wright PF, Thumar B, Burns B, Newman F, Cannon JC, Thompson J, Tsai T, Paschalis M, Wu SL, Mitcho Y, Hackell J, Murphy BR, Tatem JM. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J. 2003 May;22(5):394-405. doi: 10.1097/01.inf.0000066244.31769.83.

  PMID: 12792378 BACKGROUND

• Durbin AP, Karron RA. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis. 2003 Dec 15;37(12):1668-77. doi: 10.1086/379775. Epub 2003 Nov 20.

  PMID: 14689350 BACKGROUND

Study Officials

• Coleen K. Cunningham, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

PR (1); US (7)